Individualized Inspired Oxygen Fraction Titration During Lung Surgery (iOXY-LUNG) (iOXY-LUNG)
Individualized Inspired Oxygen Titration Versus Pure Oxygen During Lung Surgery (iOXY-LUNG): a Randomized Clinical Trial
The goal of this clinical trial is to determine whether individualized oxygen adjustment during lung surgery lowers the risk of major complications. The study will include adults undergoing planned surgery on one lung that requires more than one hour of one-lung ventilation. One-lung ventilation means that only one lung is ventilated during part of the operation.
The main question is:
Does individualized oxygen adjustment, compared with continuous 100% oxygen, lower the risk of death or major complications within 30 days after surgery?
Researchers will enroll 628 participants at three hospitals in China. Participants will be randomly assigned to two groups:
- Individualized inspired oxygen titration group: The anesthesiologist will adjust the oxygen concentration according to blood oxygen saturation, measured continuously using a pulse oximeter.
- Pure oxygen group: The anesthesiologist will maintain 100% oxygen from the start of general anesthesia until removal of the tracheal tube.
Both groups will receive 100% oxygen before one-lung ventilation begins. In the individualized group, oxygen adjustment will continue after ventilation of both lungs resumes. Before removal of the tracheal tube, the anesthesiologist may raise the oxygen concentration for safety. Both groups will receive treatment if blood oxygen levels become too low.
Researchers will assess participants during hospitalization and through 30 days after surgery. Follow-up after discharge will take place by telephone or outpatient assessment. Researchers will compare deaths and major complications affecting the lungs, heart, brain, or kidneys. They will also assess recovery and safety.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Shanghai、中国、200433
- Shanghai Pulmonary Hospital
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接触：
- Juan Wei, Ph.D
- 电话号码：86 13671658073
- 邮箱：sudaweijuan@163.com
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接触：
- Xin Lv, Ph.D
- 邮箱：xinlvg@126.com
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Anhui
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Hefei、Anhui、中国、230001
- Anhui Provincial Cancer Hospital
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接触：
- Wan Yang
- 电话号码：0551-65327751
- 邮箱：chinayangwan@163.com
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Jiangsu
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Nanjing、Jiangsu、中国、210003
- The Second Hospital of Nanjing
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接触：
- Dongming Xie
- 电话号码：025-58006129
- 邮箱：xiedongming2026@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Able and willing to provide written informed consent.
- Age 18 years or older.
- Scheduled for elective unilateral lung surgery requiring one-lung ventilation, with an anticipated one-lung ventilation duration of more than 1 hour.
- American Society of Anesthesiologists (ASA) physical status I-III.
Exclusion Criteria:
- Pregnancy or lactation.
- History of thoracic surgery.
- New York Heart Association class III-IV heart failure or Canadian Cardiovascular Society class III-IV coronary artery disease.
- Acute cardiovascular or cerebrovascular disease within the preceding 6 months or renal insufficiency requiring dialysis.
- Intracranial injury or tumor.
- Psychiatric illness, cognitive impairment, communication or language difficulties, or other circumstances expected to prevent follow-up or data collection.
- Participation in another interventional trial.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Individualized inspired oxygen fraction titration group
Participants will receive individualized inspired oxygen titration from OLV beginning |
FiO2 will be 1.0 from anesthesia induction until one-lung ventilation begins. Thereafter, FiO2 will be titrated in steps of 0.05 within 0.4-1.0 to identify the lowest concentration maintaining SpO2 ≥ 92%. At SpO2 of 90%-91%, downward titration will stop and FiO2 will be increased. SpO2 below 90% will trigger the prespecified hypoxemia rescue protocol. Titration may resume once oxygenation recovers and stabilizes, as judged by the attending anesthesiologist. The same strategy will continue after two-lung ventilation resumes. Before extubation, FiO2 may be increased for oxygen reserve. |
|
有源比较器：Pure oxygen group
The fraction of inspired oxygen (FiO2) will be maintained at 1.0 from anesthesia induction until tracheal extubation. |
FiO2 will be maintained at 1.0 from anesthesia induction until tracheal extubation, including during one-lung ventilation and after two-lung ventilation resumes. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants developing one or more major adverse events (MAEs)
大体时间：The first 30 postoperative days
|
all-cause death; postoperative pulmonary complications (pneumonia; ARDS; atelectasis; respiratory failure; pulmonary embolism; pneumothorax on the nonoperated side); cardiac events (new-onset atrial fibrillation or flutter, ventricular tachycardia or ventricular fibrillation requiring treatment; myocardial infarction; heart failure); neurological complications (stroke, transient ischemic attack, delirium); acute kidney injury defined as postoperative creatinine level at least doubled from the preoperative level or kidney replacement therapy. |
The first 30 postoperative days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
住院时间
大体时间：从手术日到出院日，直至第 90 天
|
从手术日到出院日，直至第 90 天
|
|
|
Duration of chest tube drainage
大体时间：Through study completion, an average of 3 days
|
Through study completion, an average of 3 days
|
|
|
Reintubation
大体时间：The first 30 postoperative days
|
Proportion of participants requiring tracheal reintubation after initial postoperative extubation |
The first 30 postoperative days
|
|
Hospital readmission
大体时间：The first 30 postoperative days
|
Proportion of participants readmitted to a hospital after discharge from the index hospitalization and within 30 days after surgery. |
The first 30 postoperative days
|
|
Sepsis
大体时间：The first 30 postoperative days
|
Proportion of participants developing sepsis, defined according to Sepsis-3 |
The first 30 postoperative days
|
|
Surgical site infection
大体时间：The first 30 postoperative days
|
Proportion of participants developing surgical site infection |
The first 30 postoperative days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Severe hypoxemia
大体时间：During surgery
|
Defined as peripheral oxygen saturation (SpO2) ≤85% for at least 10 seconds |
During surgery
|
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Rescue measures for hypoxemia
大体时间：During surgery
|
Proportion of participants receiving prespecified rescue measure for intraoperative hypoxemia (SpO2 below 90%) |
During surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Deidentified individual participant data underlying the published study results will be available to qualified researchers upon reasonable request. Sharing will be subject to review of the proposed research, applicable ethical approvals, institutional requirements, and data protection requirements. Individual participant data will not be publicly accessible.
IPD 共享时间框架
Requests will be considered beginning 6 months after publication of the main study results.
IPD 共享访问标准
Researchers should submit a methodologically sound research proposal and analysis plan to the corresponding author. Requests will be reviewed by the study leadership team. Access to the minimum necessary deidentified data and supporting documents will require approval of the proposal, any necessary ethical and institutional approvals, and a signed data use agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
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